Rupprecht Laura E, Koopmeiners Joseph S, Dermody Sarah S, Oliver Jason A, al'Absi Mustafa, Benowitz Neal L, Denlinger-Apte Rachel, Drobes David J, Hatsukami Dorothy, McClernon F Joseph, Pacek Lauren R, Smith Tracy T, Sved Alan F, Tidey Jennifer, Vandrey Ryan, Donny Eric C
Center for Neuroscience at the University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Division of Biostatistics, School of Public Health at the University of Minnesota, Minneapolis, Minnesota, USA.
Tob Control. 2017 Mar;26(e1):e43-e48. doi: 10.1136/tobaccocontrol-2016-053301. Epub 2016 Nov 17.
The Food and Drug Administration can reduce the nicotine content in cigarettes to very low levels. This potential regulatory action is hypothesised to improve public health by reducing smoking, but may have unintended consequences related to weight gain.
Weight gain was evaluated from a double-blind, parallel, randomised clinical trial of 839 participants assigned to smoke 1 of 6 investigational cigarettes with nicotine content ranging from 0.4 to 15.8 mg/g or their own usual brand for 6 weeks. Additional analyses evaluated weight gain in the lowest nicotine content cigarette groups (0.4 and 0.4 mg/g, high tar) to examine the effect of study product in compliant participants as assessed by urinary biomarkers. Differences in outcomes due to gender were also explored.
There were no significant differences in weight gain when comparing the reduced nicotine conditions with the 15.8 mg/g control group across all treatment groups and weeks. However, weight gain at week 6 was negatively correlated with nicotine exposure in the 2 lowest nicotine content cigarette conditions. Within the 2 lowest nicotine content cigarette conditions, male and female smokers biochemically verified to be compliant on study product gained significantly more weight than non-compliant smokers and control groups.
The effect of random assignment to investigational cigarettes with reduced nicotine on weight gain was likely obscured by non-compliance with study product. Men and women who were compliant in the lowest nicotine content cigarette conditions gained 1.2 kg over 6 weeks, indicating weight gain is a likely consequence of reduced exposure to nicotine.
NCT01681875, Post-results.
美国食品药品监督管理局可将香烟中的尼古丁含量降至极低水平。这一潜在监管行动被认为可通过减少吸烟来改善公众健康，但可能会产生与体重增加相关的意外后果。
在一项双盲、平行、随机临床试验中，对839名参与者进行了体重增加情况评估。这些参与者被分配吸食6种研究用香烟中的1种，尼古丁含量从0.4至15.8 mg/g不等，或吸食他们自己常用的品牌香烟，为期6周。额外分析评估了最低尼古丁含量香烟组（0.4和0.4 mg/g，高焦油）的体重增加情况，以通过尿液生物标志物评估研究产品在依从参与者中的效果。还探讨了因性别导致的结果差异。
在所有治疗组和各周中，将尼古丁含量降低的情况与15.8 mg/g的对照组相比，体重增加没有显著差异。然而，在2种最低尼古丁含量香烟情况下，第6周时体重增加与尼古丁暴露呈负相关。在2种最低尼古丁含量香烟情况下，经生化验证对研究产品依从的男性和女性吸烟者比不依从的吸烟者和对照组体重增加显著更多。
随机分配吸食尼古丁含量降低的研究用香烟对体重增加的影响可能因不依从研究产品而被掩盖。在最低尼古丁含量香烟情况下依从的男性和女性在6周内体重增加了1.2 kg，表明体重增加可能是尼古丁暴露减少的一个后果。
NCT01681875，结果公布后注册。
